A Study of Influenza Virus Vaccines in Children and Adults

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier:
NCT00988143
First received: October 1, 2009
Last updated: November 18, 2013
Last verified: November 2013
  Purpose

The purpose of this study is to describe the immunogenicity of the prototype Quadrivalent Influenza Vaccine (QIV) compared with the 2009-2010 Trivalent Influenza Vaccine (TIV) and the 2008-2009 TIV among children and adults.

Primary Objective:

To describe the immunogenicity of the prototype Quadrivalent Influenza Vaccine (QIV) compared with the 2009-2010 Trivalent Influenza Vaccine (TIV) and the 2008-2009 TIV among adults.

Observational Objectives:

  • To describe the safety of the 2009-2010 TIV among subjects ≥6 months to <5 years, 18-60 years, and ≥ 61 years of age, and to describe the safety of 2008-2009 TIV and prototype QIV Fluzone® vaccines among subjects 18-60 years and ≥ 61 years of age.
  • To describe the immunogenicity of the 2009-2010 TIV vaccine among subjects ≥6 months to <5 years, 18-60 years, and ≥61 years of age, and to describe the immunogenicity of 2008-2009 TIV and prototype QIV vaccines among subjects 18-60 years and ≥61 years of age.

Condition Intervention Phase
Influenza
Biological: 2009-2010 Trivalent Influenza Virus Vaccine
Biological: 2008-2009 Trivalent Influenza Virus Vaccine
Biological: Quadrivalent Influenza Virus Vaccine
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Immunogenicity and Safety Among Children and Adults of the 2009-2010 Trivalent Influenza Vaccine, 2008-2009 Trivalent Influenza Vaccine, and Quadrivalent Influenza Vaccine (Intramuscular Route)

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Quadrivalent Influenza Vaccine or Fluzone® Trivalent Influenza Vaccines. [ Time Frame: Day 0 up to 7 days post-vaccination ] [ Designated as safety issue: No ]

    Solicited injection site reactions (6-23 Months): Tenderness, Redness and Swelling; Solicited systemic reactions: Fever, Abnormal crying, Drowsiness, Loss of appetite, Vomiting and Irritability Grade 3 Tenderness: cries when injected limb is moved; Redness and Swelling: ≥5 cm; Fever: >103.1°F; Abnormal crying: >3 hours; Drowsiness: Sleeping most of the time; Loss of appetite: refuses ≥3 feeds/meals; Vomiting: ≥6 episodes/24 hours; Irritability: inconsolable.

    (24-59 Months): Pain, Redness and Swelling; Fever, Headache, Malaise and Myalgia. Grade 3: Pain, Incapacitating; Redness and Swelling: ≥5 cm; Fever: >102.1°F, Headache, Malaise and Myalgia: Significant, prevents daily activity.

    (Adults): Pain, Redness, Induration, and Ecchymosis; Fever, Headache, Malaise, Myalgia and Shivering.

    Grade 3: Pain: significant, prevents daily activities; Redness, Swelling, Induration and Ecchymosis: >10 cm; Fever >102.1°F; Headache, Malaise, Myalgia & Shivering: Significant, prevents daily activity.


  • Geometric Mean Titers (GMTs) Against Influenza B Strains After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccine in Adult Participants. [ Time Frame: 21 Days post last vaccination ] [ Designated as safety issue: No ]
    Immunogenicity outcomes were assessed in serum samples by Hemagglutination inhibition (HAI) assay. The lower limit of quantitation (LLOQ) was set at the lowest dilution used in the assay, 1/10. Titers below this level were reported as <10.

  • Geometric Mean Titers (GMTs) Against Influenza A Strains After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccine in Adult Participants. [ Time Frame: 21 Days post last vaccination ] [ Designated as safety issue: No ]
    Immunogenicity outcomes were assessed in serum samples by Hemagglutination inhibition (HAI) assay. The lower limit of quantitation (LLOQ) was set at the lowest dilution used in the assay, 1/10. Titers below this level were reported as <10.


Other Outcome Measures:
  • Number of Adult Participants With Seroprotection Against Influenza Vaccine Antigens Following Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccine [ Time Frame: Day 0 (pre-vaccination) and Day 21 post final vaccination ] [ Designated as safety issue: No ]

    Immunogenicity outcomes were assessed in serum samples by HAI assay. The lower limit of quantitation (LLOQ) was set at the lowest dilution used in the assay, 1/10. Titers below this level were reported as <10.

    Seroprotection to vaccine antigens was defined as a pre-vaccination and post-vaccination titer value of titer ≥ 40 (1/dil)


  • Geometric Mean Titers Against the Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in Adult Participants [ Time Frame: 21 Days post last vaccination ] [ Designated as safety issue: No ]
    Immunogenicity outcomes were assessed in serum samples by HAI assay. The lower limit of quantitation (LLOQ) was set at the lowest dilution used in the assay, 1/10. Titers below this level were reported as <10.

  • Number of Adult Participants With Seroconversion to Vaccine Antigens Following Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines [ Time Frame: Day 21 post-vaccination ] [ Designated as safety issue: No ]
    Seroconversion to vaccine antigens was defined as a pre-vaccination titer < 10 (1/dil) and a post-vaccination titer ≥ 40 (1/dil), or a pre-vaccination titer ≥ 10 (1/dil) and a ≥ 4-fold increase in post-vaccination titer.

  • Geometric Mean Titers Against the Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in All Study Participants [ Time Frame: 21 Days post last vaccination ] [ Designated as safety issue: No ]
    Immunogenicity outcomes were assessed in serum samples by HAI assay. The lower limit of quantitation (LLOQ) was set at the lowest dilution used in the assay, 1/10. Titers below this level were reported as <10.

  • Number of Participants With Seroconversion to Influenza Vaccine Antigens Following Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines [ Time Frame: Day 0 up to 21 days post-vaccination ] [ Designated as safety issue: No ]
    Seroconversion to vaccine antigens were defined as a pre-vaccination titer < 10 (1/dil) and a post-vaccination titer ≥ 40 (1/dil), or a pre-vaccination titer ≥ 10 (1/dil) and a ≥ 4-fold increase in post-vaccination titer.

  • Number of Participants With Seroprotection to Influenza Vaccine Antigens Following Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines [ Time Frame: Day 0 (pre-vaccination) and Day 21 post final vaccination ] [ Designated as safety issue: No ]

    Immunogenicity outcomes were assessed in serum samples by HAI assay. The lower limit of quantitation (LLOQ) was set at the lowest dilution used in the assay, 1/10. Titers below this level were reported as <10.

    Seroprotection to vaccine antigens was defined as a pre-vaccination and post-vaccination titer value of titer ≥ 40 (1/dil).



Enrollment: 600
Study Start Date: October 2009
Study Completion Date: March 2010
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Study Group 1
Participants will receive the 2009-2010 Trivalent Influenza Vaccine (TIV) (Pediatric dose have no preservatives)
Biological: 2009-2010 Trivalent Influenza Virus Vaccine
0.25 mL, Intramuscular (participants at 6 to 35 months of age - Pediatric Dose); Others 0.5 mL, Intramuscular.
Other Name: Fluzone®
Active Comparator: Study Group 2
Participants will receive the 2008-2009 Trivalent Influenza Vaccine (TIV)
Biological: 2008-2009 Trivalent Influenza Virus Vaccine
0.25 mL, Intramuscular; 0.5 mL, Intramuscular.
Other Name: Fluzone®
Active Comparator: Study Group 3
Participants will receive the Quadrivalent Influenza Vaccine (QIV)
Biological: Quadrivalent Influenza Virus Vaccine
0.5 mL, Intramuscular

  Eligibility

Ages Eligible for Study:   6 Months and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria :

  • Subject is ≥ 6 months to < 5 years of age or 18 years of age or older on the day of inclusion.
  • Parent/legal guardian (if the subject is ≥ 6 months to < 5 years of age) or adult subject (if 18 years of age or older) is willing and able to attend scheduled visits and to comply with the study procedures during the entire duration of the study.
  • Subject in reasonably good health as assessed by the Investigator.
  • Parent/legal guardian (if the subject is ≥ 6 months to < 5 years of age) or adult subject (if 18 years of age or older) is willing and able to give informed consent.
  • For subjects ≥ 6 months to < 5 years of age: subject was born at full term of pregnancy (≥ 37 weeks) with a birth weight ≥ 2.5 kg (5.5 lbs).
  • For a woman, inability to bear a child or negative serum/urine pregnancy test, if applicable.

Exclusion Criteria :

For all subjects:

  • History of allergy to egg proteins, chicken proteins, or one of the constituents of the vaccine, such as thimerosal or formaldehyde.
  • History of serious adverse reaction to any influenza vaccine.
  • Laboratory-confirmed influenza infection or vaccination against influenza in the six months preceding enrollment in the study.
  • Any vaccination scheduled between Visit 1 and Visit 2 or Visit 3.
  • Participation in any other interventional drug or vaccine trial during participation in this study.
  • Thrombocytopenia or bleeding disorder contraindicating intramuscular vaccination.
  • Any condition that in the opinion of the Investigator would pose a health risk to the subject if enrolled or could interfere with the evaluation of the vaccine.
  • Prior personal history of Guillain-Barré syndrome.

For subjects > 6 months to < 5 years of age:

  • Known or suspected impairment of immunologic function or receipt of immunosuppressive therapy or immunoglobulin since birth.
  • Personal or immediate family history of congenital immune deficiency.
  • Developmental delay, neurologic disorder, or seizure disorder.
  • Chronic medical, congenital, or developmental disorder.
  • Known HIV-positive mother.

For subjects 18 years of age and older:

  • Immunocompromising condition; immunosuppressive therapy (including systemic steroid use for two weeks or more); cancer chemotherapy or radiation therapy at the time of enrollment, planned during the period of this study, or at any time within the past six months.
  • Diabetes mellitus requiring pharmacological control.
  • Person deprived of freedom by an administrative or court order (having legal or medical guardian).
  • For women of childbearing potential, a positive urine pregnancy test, breast feeding, or not using a medically approved and reliable form of contraception (oral contraceptives or double barrier method) for the duration of the trial.
  • Current use of alcohol or recreational drugs that may interfere with the subject's ability to comply with trial procedures.
  • Any subject with the following conditions is not eligible for enrollment. However, the subject may be enrolled subsequently if the condition has resolved and enrollment is still ongoing and the subject meets all other inclusion/exclusion criteria:

    • An acute illness with or without fever in the 72 hours preceding enrollment in the trial.
    • Clinically significant findings in vital signs or review of systems (Investigator judgment).
    • Received any vaccinations within the preceding 14 days.
    • Participation in any other interventional clinical trial within 30 days prior to enrollment.
    • Receipt of blood or blood products within the three months preceding enrollment in the study.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00988143

Locations
United States, North Carolina
Durham, North Carolina, United States, 27704
United States, Ohio
Cincinnati, Ohio, United States, 45249
United States, Pennsylvania
Jefferson Hills, Pennsylvania, United States, 15025
United States, Virginia
Norfolk, Virginia, United States, 23507
Sponsors and Collaborators
Sanofi Pasteur, a Sanofi Company
Investigators
Study Director: Medical Director Sanofi Pasteur Inc.
  More Information

Additional Information:
No publications provided

Responsible Party: Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier: NCT00988143     History of Changes
Other Study ID Numbers: GRC43, UTN: U1111-1111-5427
Study First Received: October 1, 2009
Results First Received: July 3, 2013
Last Updated: November 18, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Sanofi:
Influenza
Trivalent Influenza Virus Vaccine
Quadrivalent Influenza Virus Vaccine

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
Respiratory Tract Diseases
Respiratory Tract Infections
RNA Virus Infections
Virus Diseases

ClinicalTrials.gov processed this record on October 21, 2014